BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1082315 · Received July 23, 2008

    Report

    Report Number
    2649622-2008-04023
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    May 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWP
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY PVR449101H NO ANOMALIES FOUND; NO ANOMALIES FOUND; FULL LEAD RETURNED; NO ANOMALIES FOUND; FULL LEAD RETURNED; NO ANOMALIES FOUND; FULL LEAD RETURNED. CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD LWP MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention